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A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners


N/A
18 Years
N/A
Open (Enrolling)
Both
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Sexual Dysfunction, Sexuality and Reproductive Issues

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Trial Information

A Pilot Study of an Intimacy-Enhancing Couples Therapy for Men With Advanced Prostate Cancer and Their Partners


OBJECTIVES:

- Determine the feasibility of Intimacy-Enhancing Couples Therapy (IECT) for patients
with advanced or recurrent prostate cancer and their partners.

- Compare the effect of IECT vs usual care on patients' and their partners' level of
global psychological distress.

- Compare the effect of IECT vs usual care on relationship intimacy in these
participants.

OUTLINE: This is a randomized, controlled, pilot, multicenter study. Patients are stratified
according to marital distress based on partners' scores on the Abbreviated Dyadic Adjustment
Scale (high [< 21] vs low [≥ 21]). Patients and their partners are randomized to 1 of 2
arms.

- Arm I: Patients and their partners receive Intimacy-Enhancing Couples Therapy over 6
weeks comprising the following four 90-minute sessions: the Story of Cancer;
Understanding the Couple, Ways of Relating and Key Influences; Intimacy; and Coping,
Support, and Adaptation. Patients and their partners complete treatment satisfaction
questionnaires after completion of study intervention.

- Arm II: Patients and their partners receive standard psychosocial care. All
participants complete questionnaires assessing psychological distress, intimacy,
communication patterns, and overall relationship adjustment/satisfaction at baseline
and at 1 month after completion of study intervention.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary prostate cancer

- Advanced or recurrent disease

- Receiving concurrent hormonal therapy

- Married and/or co-habitating with a partner for ≥ 1 year

- T-score > 50 on Brief Symptom Inventory-18 questionnaire (patient and/or partner)

PATIENT CHARACTERISTICS:

- Normal cognitive functioning

- Able to speak and read English

- No significant hearing impairment that would preclude study participation

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Feasibility of Intimacy-Enhancing Couples Therapy (IECT) (e.g., eligibility rate, acceptance rate, attendance rate, satisfaction) assessed at baseline and at 1 month after completion of study intervention

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Talia Zaider, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-043

NCT ID:

NCT00483678

Start Date:

April 2007

Completion Date:

April 2014

Related Keywords:

  • Prostate Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • psychosocial effects of cancer and its treatment
  • sexual dysfunction
  • sexuality and reproductive issues
  • recurrent prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms
  • Sexual Dysfunctions, Psychological

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer Center - CheltenhamPhiladelphia, Pennsylvania  19111-2497